In Vivo Dosimetry for Brachytherapy Study | NCT06863090

Studies
In Vivo Dosimetry for Brachytherapy Study

NCT06863090

Sponsor

East and North Hertfordshire NHS Trust

Status

Recruiting

Last Update Posted

Mar 11, 2025Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Prostate Cancer
Gynaecological Cancer

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2025Estimated

Primary Completion Date

Mar 1, 2026Estimated

Completion Date

Mar 1, 2026Estimated

First Submitted Date

Mar 3, 2025

First Submission Date that Met QC Criteria

Mar 3, 2025

First Posted Date

Mar 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2025

Last Update Posted Date

Mar 11, 2025Actual

Name	Class
TRUEinvivo Limited	UNKNOWN

Description Module

Brief Summary

The main study aim is the investigate the clinical use of in vivo dosimeters (small measurement devices) for brachytherapy (internal radiotherapy).

Detailed Description

A dosimeter is a small device that is able to record the dose of radiation received. It can provide an independent check that the dose of radiation delivered matches the dose calculated for patients receiving radiotherapy as part of their cancer treatment.

The purpose of this study is to investigate the clinical use of in vivo dosimeters for brachytherapy. Two types of dosimeters will be used; micro metal oxide field effect transistors (microMOSFETs) and Thermoluminescent detectors (TLDs). These will be placed into the rectum (back passage), urethra (the tube through which urine leave the body from the bladder) and within or near (typically within a few centimetres) to the cancer itself. These devices will record the dose of radiation received at the time of brachytherapy at each of these sites and we will compare that measurement with the expected measurement based on the calculations we made in planning the patient's treatment.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
Prostate cancer patients		histologically proven primary or recurrent prostate cancer
Gynaecological cancer patient		locally advanced gynaecological malignancy in the primary and recurrent setting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the feasibility of in vivo dosimetry in HDR brachytherapy and compare the calculated dose against measured dose	Measured by comparing the calculated (treatment planning system (TPS)) dose against the measured dose (using micro silica thermo-luminescent dosimeters (TLDs) and micro metal oxide field effect transistors (MOSFETS)). The measured dose will be compared to the calculated dose by the TPS at the bladder neck, anterior rectal wall, recto-vaginal point (gynaecological cases) and within the clinical target volume (CTV) for each fraction as well for the whole treatment.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Review of investigative and corrective action	Measured by defined action thresholds during high-dose rate (HDR) brachytherapy	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 18 years and above
Patients receiving HDR brachytherapy using iridium-192 (192Ir) radioactive source either as a monotherapy or in combination with external beam radiotherapy for:
1. histologically/radiologically proven primary or locally recurrent prostate cancer
2. locally advanced gynaecological malignancy in the primary and recurrent setting
  - primary cervix carcinoma (squamous, adenocarcinoma, adenosquamous) FIGO IB2-IVA
  - primary vulval FIGO I-IVA
  - primary vaginal FIGO I-IVA
  - primary endometrial cancer FIGO Stage I-IVA (not suitable for surgery)
  - endometrial cancer receiving adjuvant vaginal vault brachytherapy
  - recurrent cervix, vulval, vaginal or endometrial cancer suitable for brachytherapy as discussed in a regional gynae-oncology multidisciplinary meeting.
World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

Previous brachytherapy exposure to the treatment site
Patients unable to give informed consent
Patients unable to have a regional or general anaesthetic
Patients with the following medical conditions: coagulopathies, history of another primary malignancy, known allergy or sensitivity to study materials; previous or current fistulae
Not able to understand the implications of participating in the study in English
Patients with recent (within the last 6 months) or currently participating in interventional research

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving high dose rate (HDR) brachytherapy for gynaecological and prostate cancers

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Rishma Bhatti	Contact	0203 826 2020		mvccresearch/enh-tr@nhs.net
Amani Chowdhury	Contact			amani.chowdhury@nhs.net

Name	Affiliation	Role
Peter Hoskin	East and North Hertfordshire NHS Trust	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mount Vernon Cancer Centre	Recruiting	Northwood	Middlesex	HA62RN	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The research results will be published in international journals and presented at scientific meetings.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms